Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis (ATLAS)

Abbott

Status and phase

Completed

Phase 3

Conditions

Ankylosing Spondylitis

Treatments

Biological: adalimumab (D2E7)

Biological: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00085644

M03-607

Details and patient eligibility

About

The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).

Enrollment

315 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must be >= 18 years of age
meet Modified NY Criteria definition of ankylosing spondylitis (AS)
have diagnosis of active AS based on protocol specified criteria
inadequate response or intolerance to >= 1 nonsteroidal antiinflammatory drug (NSAID)
be able and willing to learn to self-administer subcutaneous (SC) injections

Exclusion criteria

Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C
History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease
Previous anti-tumor necrosis factor therapy
Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine)
Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing
Biologic or investigational therapy within 6 weeks of study dosing
Treatment with intravenous (IV) antibiotics within 30 days of study dosing
Treatment with oral antibiotics within 14 days of study dosing